Recorded March 10, 2021 | On-Demand Webinar
Assess historical and current standards of approval. Discuss what standard FDA uses to approve a BLA submitted under section 351(a) of the Public Health Service Act (PHSA). Outline what is in a section 351(a) BLA. Understand FDA’s review and decision processes.
This session was recorded as part of FDLI’s virtual Introduction to Biologics and Biosimilars Law and Regulation course in March 2021.